Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nilotinib
Drug ID BADD_D01567
Description Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.
Indications and Usage For the potential treatment of various leukemias, including chronic myeloid leukemia (CML).
Marketing Status Prescription
ATC Code L01EA03
DrugBank ID DB04868
KEGG ID D08953
MeSH ID C498826
PubChem ID 644241
TTD Drug ID D00STL
NDC Product Code 0078-0592; 0078-0951; 76302-015; 0078-0526; 54893-0069
Synonyms nilotinib | 4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide | nilotinib hydrochloride dihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:1:2) | nilotinib hydrochloride anhydrous | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride (1:1) | nilotinib hydrochloride | nilotinib hydrochloride hydrate | Tasigna | nilotinib hydrochloride monohydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate | nilotinib hydrochloride sesquihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (2:2:3) | nilotinib dihydrochloride dihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:2:2) | AMN107 | AMN-107 | AMN 107
Chemical Information
Molecular Formula C28H22F3N7O
CAS Registry Number 641571-10-0
SMILES CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=C(N=C3)C)NC4=NC=CC(=N4)C5=CN=CC= C5
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Biliary colic09.02.01.0010.000799%Not Available
Bilirubin conjugated increased13.03.01.0070.001598%Not Available
Bladder cancer16.08.01.001; 20.03.04.001--Not Available
Bladder neoplasm16.08.03.002; 20.03.04.0020.000799%Not Available
Bladder pain20.02.02.0010.000533%Not Available
Blepharitis06.04.04.001; 23.03.04.0120.001066%Not Available
Blindness06.02.02.001; 17.17.01.0030.005062%Not Available
Blindness transient06.02.02.002; 17.17.01.0040.000533%Not Available
Blindness unilateral06.02.02.009; 17.17.01.0160.002931%Not Available
Blister12.01.06.002; 23.03.01.001--Not Available
Blood albumin decreased13.09.01.001--Not Available
Blood bilirubin increased13.03.01.0080.028506%
Blood bilirubin unconjugated increased13.03.01.024--Not Available
Blood calcium decreased13.11.01.0020.001598%Not Available
Blood calcium increased13.11.01.003--Not Available
Blood cholesterol increased13.12.01.0020.008259%
Blood creatine phosphokinase increased13.04.01.0010.014653%
Blood creatinine decreased13.13.01.0030.001066%Not Available
Blood creatinine increased13.13.01.0040.006927%
Blood fibrinogen decreased13.01.02.0030.000533%
Blood glucose abnormal13.02.02.0080.001332%Not Available
Blood glucose decreased13.02.02.001--Not Available
Blood glucose increased13.02.02.0020.019981%Not Available
Blood insulin decreased13.10.02.005--Not Available
Blood insulin increased13.10.02.001--Not Available
Blood iron decreased13.11.01.0060.001865%Not Available
Blood lactate dehydrogenase increased13.04.02.0020.005062%
Blood magnesium decreased13.11.01.0080.000533%Not Available
Blood parathyroid hormone increased13.10.07.002--Not Available
Blood potassium decreased13.11.01.010--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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